EUCTR2009-013539-39-FR进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Psoriasis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 175
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subject is capable of understanding and giving written, voluntary informed consent before study screening.
- •Male or female = 18 and = 70 years of age at time of screening.
- •Subject has had stable moderate to severe plaque psoriasis for at least 6 months (eg, no morphology changes or significant flares of disease activity in the opinion of the investigator).
- •Subject has received at least 1 previous phototherapy or systemic psoriasis
- •therapy, ie, PUVA therapy, cyclosporine or methotrexate.
- •Subject has involved BSA = 10% and PASI = 12 at screening and at baseline.
- •Subject has a negative test for hepatitis B virus (HBV) surface antigen, hepatitis C virus (HCV) antibody, and HIV.
- •Subject has a negative serum pregnancy test within 28 days before initiating IP for female subjects (except those at least 3 years postmenopausal or surgically sterile) and a negative urine pregnancy test at baseline.
- •Subject has a negative purified protein derivative (PPD) test within 30 days prior to the first IP dose. Tuberculin skin tests should be considered positive when they have = 5 mm of induration at 48 to 72 hours after test is placed. Subjects with a positive tuberculin skin test (if = 14 mm of induration) may enroll if they have a history of Bacillus Calmette-Guerin vaccination with a negative Quantiferon test in the past year, no symptoms per tuberculosis worksheet, and a negative chest X-ray.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Skin disease related
- •Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced, or medication-exacerbated psoriasis.
- •Evidence of skin conditions at the time of the screening visit (eg, eczema, guttate psoriasis) that would interfere with evaluations of the effect of IP on psoriasis.
- •Other medical conditions
- •Subject has a planned surgical intervention for a pretreatment condition within the duration of the study, including the follow-up period.
- •Subject has any active CTCAE grade 2 (localized infection, local intervention indicated) or higher infection (including chronic or localized infections) within 30 days prior to screening, at screening, or during screening period prior to first IP dose.
- •Subject has a serious infection, defined as requiring hospitalization or IV antibiotics within 8 weeks before screening.
- •Subject has recurrent or chronic infections, defined as = 3 infections requiring anti-microbials over the past 12 months prior to screening.
- •Subject has a significant concurrent medical condition, including:
- •- Type 1 diabetes.
- •- Poorly controlled type 2 diabetes (Hemoglobin A1c > 8.5).
- •- Symptomatic heart failure (New York Heart Association class II, III, or IV).
- •- Myocardial infarction within the last year.
- •- Current or history of unstable angina pectoris within the last year.
- •- Uncontrolled hypertension as defined by resting blood pressure > 150/90 mmHg prior to randomization (confirmed by a repeat assessment).
- •- Severe chronic pulmonary disease (eg, requiring oxygen therapy).
- •- Major chronic inflammatory disease or connective tissue disease other than psoriasis with or without arthritis.
- •- Multiple sclerosis or any other demyelinating disease.
- •- Active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma, or history of cancer (except successfully treated in situ cervical cancer or squamous or basal cell carcinoma of the skin).
- •- Any condition that, in the opinion of the investigator, might cause this study to be detrimental to the subject.
- •Subject is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, up to the subject’s last study visit including the 30-day follow-up period.
- •Female subject is not willing to abstain from sexual intercourse or use 2 highly effective forms of birth control for the duration of the study including the follow-up period (except women at least 3 years postmenopausal or surgically sterile). Highly effective methods of birth control for women include but are not limited to birth control pills, Depo-Provera® injections, contraceptive implants, or occlusive cap (barrier method) in combination with barrier methods used by the man.
- •Male subject is not willing to abstain from sexual intercourse or use 2 highly effective forms of birth control for the duration of the study including the follow-up period, plus an additional 4 weeks (except for men who are surgically sterile or whose female partners are at least 3 years postmenopausal or surgically sterile). Highly effective methods of birth control include but are not limited to a condom in combination with hormonal birth control or barrier methods used by the woman.
- •Male subject (including vasectomised males) with a pregnant female partner is not willing to use effective methods to ensure that an unborn child is not exposed to AMG 827 via semen. Effective methods to ensure that an unborn child is not exposed to AMG 827 via semen include condoms or abstinence.
研究者
相似试验
招募中
3 期
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Inclacumab in Participants with Sickle Cell Disease Experiencing Vaso-occlusive CrisesPatients with a diagnosis of sickle cell disease who have experienced between 2 and 10 vaso-occlusive crises in the 12 months preceding enrollment in this study.SCD, vaso-occlusive crisis, blood disorders, hemoglobin, red blood cells, sickle-like shape, mutation in hemoglobin gene, sickle-cell trait, sickle-cell crisis, Sickle Cell Disease SCD, Hydroxyurea/ Hydroxycarbamide Therapy, SCALBCTR2021064791Global Blood Therapeutics, Inc.240
未知
1 期
A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Evaluate the Safety and Tolerability of a Once Daily Dose of 50 mg E2609 in Healthy Japanese SubjectsHealthy Japanese SubjectJPRN-jRCT2080223449Eisai Co., Ltd.16
进行中（未招募）
不适用
A Randomized, Double-blind, Placebo-controlled, Multi-centre Phase III Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) Compared to Placebo in Patients with Locally Advanced and/or Metastatic Renal Cell CarcinomaEUCTR2005-004078-25-CZGlaxoSmithKline Research & Development Limited400
招募中
1 期
A study to understand the safety and the effects of a virus that transfers a modified protein responsible for copper metabolism (copper-transporting P-type adenosine triphosphatase, ATP7B) in adults with Wilson disease.Wilson diseaseMedDRA version: 20.0Level: LLTClassification code: 10047988Term: Wilson's disease Class: 10010331CTIS2022-502873-40-00ltragenyx Pharmaceutical Inc.87
进行中（未招募）
1 期
Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasismoderate to severe palmoplantar psoriasisMedDRA version: 15.1Level: LLTClassification code 10037158Term: Psoriasis palm & solesSystem Organ Class: 100000004858EUCTR2012-005412-25-ESovartis Farmacéutica, S.A.201